Targeting Guide and Associated Method

This application is a continuation filed under 37 C.F.R. § 1.53 claiming the benefit under 35 U.S.C. § 120 of any and all applications for which a foreign or domestic priority claim is identified in the Application Data Sheet as filed with the present application, including U.S. patent application Ser. No. 17/759,627, filed Jul. 28, 2022, International Patent Application No. PCT/US2020/059351, filed Nov. 6, 2020, and U.S. Provisional Patent Application No. 63/001,610, filed Mar. 30, 2020, and are hereby incorporated by reference in accordance with 37 C.F.R. §§ 1.57; 1.97; and 1.98 in their entireties.

The disclosed system and method relate to the field of correcting anatomical structures. More particularly, the disclosed systems and methods relate to correcting defects in anatomical structures in the lower extremities of a patient.

Hallux valgus deformities (also known as bunions) occur when a metatarsal goes into a varus state (i.e., is pointed inwardly). In addition to being pointed inward, the metatarsal also may be rotated about its longitudinal axis such that the bottom of the bone is facing outwardly, which may result in the sesamoid being pointed outwardly when it should be located underneath the metatarsal. Correction of a bunion typically requires surgery, such as a digital metatarsal osteotomy, to fuse the TMT1 joint (i.e., the joint between the first metatarsal and first cuneiform).

In some embodiments, a system includes a base and a targeting guide coupled to the base. The base includes a first member and a second member. The first member defines a first hole for receiving a first fixation element for coupling the first member to a bone. The second member is pivotably coupled to the first member. The second member defines a second hole and a third hole. The second hole is for receiving a second fixation element for coupling the second member to a bone, and the third hole is for receiving an adjustment member for adjusting an angle between the first member and the second member. The targeting guide extends from a first end to a second end and defines a fourth hole adjacent to the second end of the targeting guide. The fourth hole is sized and configured to receive a fixation device therein.

In some embodiments, a system includes a base and a targeting member configured to be positioned relative to the base. The base includes first and second members that are coupled together in a pivoting arrangement. The first member includes a first hole for receiving a first fixation element for coupling the first member to a first bone portion and a second hole for receiving an adjustment member for adjusting an angle between the first and second members. The second member has an adjustable length and defines at least one hole for receiving at least one second fixation element for coupling the second member to a second bone portion. The targeting member defines at least one hole for guiding at least one third fixation element into engagement with the first and second bone portions.

In some embodiments, a method includes inserting a first fixation element through a first hole defined by a first member of a base of a tool; inserting a second fixation element through a second hole defined by a second member of the base of the tool; adjusting an angle between the first member and the second member with a first adjustment member; and positioning a targeting member relative to the tool such that the first fixation element is at least partially received within a first hole defined adjacent to a first end of the targeting member.

This description of the exemplary embodiments is intended to be read in connection with the accompanying drawings, which are to be considered part of the entire written description.

illustrate one example of a system in accordance with some embodiments. In some embodiments, system may be used to facilitate a distal metatarsal osteotomy for bunion correction via a minimally invasive surgical (MIS) procedure. Referring first to, a basemay include an anchor memberthat is coupled to an angled bodyvia a pivoting arrangement. In some embodiments, the pivot pointabout which anchor memberand bodymay pivot is located along an axis defined by holeformed in anchor memberand a holeformed through a first componentof bodyas described in greater detail below.

provide various view of an anchor memberin accordance with some embodiments. Referring first to, the holedefined by anchor memberextends through first and second hinge components-,-(collectively, “hinge components”) that are separated from one another by a gap.

Anchor membermay define a threaded holeextending from a first sideto a second side. Threaded holemay be sized and configured to engage thumb screwas shown inand described in greater detail below. Another holemay extend from sidethrough anchor memberto side. In some embodiments, holeis disposed parallel to holeand perpendicular to hole. Holesandmay be sized and configured to receive fixation elements, such as a pins or k-wires, for coupling anchor memberto a bone or bone segment as described herein.

In some embodiments, bodyincludes a first componentand a second componentthat are coupled together such that componentmay move relative to first component. A person of ordinary skill in the art will further understand that, although bodyis described as including multiple components, bodymay be provided as a unitary member. As shown in, which is an isometric view of componentof body, one endof componentincludes one or more hinge components-,-,-(collectively, “hinge components”) that are configured to engage hinge componentsof anchor member. For example, hinge componentsare spaced apart from one another by gaps-,-(collectively, “gaps”). Note that while three hinge componentsand two gapsare shown infewer or more hinge componentsand gapsmay be provided. Each of the hinge componentsdefines a holethat is sized and configured to receive a fixation element, such as a k-wire or pin, for coupling the bodyto a bone or bone segment. In some embodiments, hinge componentsextend at an angle away from a longitudinal axis defined by componentbetween endand end.

Componentmay include a portionhaving a reduced size (e.g., width) such that one or more shoulders-,-(collectively, “shoulders”) are provided adjacent to end. One or more channels-,-(collectively, “channels”) extend from endtowards endalong the portion. Componentmay also define a hole, which may be at least partially threaded, that extends through componentfrom endto end.

One example of the second componentis illustrated in. Componentextend from a first sideto a second sideand is substantially hollow. For example, sidedefines an openingthat extends inwardly into component(), and sidedefines a hole() that is in communication with opening. Openingmay extend to a depth such that a majority of the length of the first component, or at least a substantial portion of the reduced size portionof component, may be received within opening.

One or more protrusions-,-(collectively, “protrusions”) may extending inwardly into opening. Protrusionsare sized and configured to align with and be received within channelsthat extend along component. Although protrusionsare shown as being part of componentand channels are shown as being defined by component, one of ordinary skill in the art will understand that the configuration could be reversed and/or each component,could include a combination of a protrusion and a channel. Furthermore, in some embodiments, componentsandmay be configured to rotate relative to one another. For example, componentmay be configured to rotate about the longitudinal axis of componentor provide for relative positioning of componentsandthat may enable a bone (or bone segment), such as a first metatarsal, coupled to one of the components (e.g., component) to be rotated about a longitudinal axis of the bone.

Componentalso may define one or more holesthat extend laterally through the component. More particularly, the one or more holesmay be disposed adjacent to sideand extend from sideto side. Holeis sized and configured to receive a fixation element, such as a k-wire or pin, for securing the componentto a bone or bone segment.

illustrates how the anchor membermay be coupled to the componentof the angled bodyand how componentis coupled to componentof angled body. The hinge elementsof anchor memberare aligned with the gapsbetween the hinge elementsof body. The holes,defined by the hinge elementsof anchor memberand defined by the hinge elementsof bodyare then aligned with one another and a coupling element, such as a spring pin(best seen in), is inserted through the aligned holes.

The body componentsandof bodyare coupled together by respectively aligning the openingand protrusions of componentwith the portionand channelsof component. Once aligned with one another, the componentmay be slid along the reduced size portionof component. An adjustment bolt(shown in, may be received within holedefined by body componentand within threaded holedefined by body component. Rotation of the adjustment boltcauses relative translation of the first and second components,. For example, rotation of the adjustment boltin a first direction (e.g., clockwise) may result in the second componentmoving along first componentand thereby shortening a length of body, and rotation of the adjustment boltin a second direction (e.g., counterclockwise) may result in the second componentmoving along first componentand thereby increasing a length of body. As best seen in, the adjustment boltincludes a threaded portionand an enlarged head. The head may include an engagement feature, which may be configured to receive a driving tool (e.g., a screwdriver, hex key, star driver). In some embodiments, the adjustment bolt may be engaged to componentwith dowel pins (not shown) that may be received within holes-,-(collectively, “holes”) best seen in.

Referring now to, a thumb screwmay be provided for adjusting an angle between anchor memberand body. Thumb screwincludes a threaded portionthat is configured to be received within holedefined by anchor member. Thumb screwalso may include an enlarged head(i.e., has a larger diameter than threaded portion) that prevents the headfrom being received within holeand provides a surgeon with an increased surface area to manipulate the thumb screw.

Referring to, the baseis shown coupled to a bone B, which has been cut into two segments B-, B-. In some embodiments, the bone B is a metatarsal; however, one of ordinary skill in the art should understand that the disclosed system may be used with other bones. Further, it should be understood that the basemay be coupled to the bone B before or after the bone is resected into segments B-, B-. Anchor memberis coupled to bone B with a first fixation element P-, e.g., a pin or k-wire, that is inserted through holedefined by anchor member.

Another fixation element P-couples both the anchor memberand bodyto the bone B. More particularly, fixation element P-is inserted through the coupling element, which extends between holedefined by anchor memberand holedefined by componentof body. Componentof bodymay be separately coupled to bone B, and more particularly to the bone segment B-that may be a metatarsal head, by inserting a fixation element P-through lateral hole.

As noted above, the basemay be coupled to the bone B before or after the bone is segmented into one or more segments B-, B-. Regardless of when the baseis coupled to the bone, the basemay be used to adjust the alignment of the segments B-and B-relative to one another. For example, thumb screwmay be used to move bone segment B-(e.g., a severed distal metatarsal head) medially or laterally with respect to the remainder of the metatarsal by rotating the thumb screw. Rotating the thumb screwin a first direction (e.g., clockwise) may cause the thumb screwto be advanced into holedefined by anchor member, which in turn causes thumb screwto press against bodysuch that bodypivots about pivot point.

In embodiments in which bodyincludes plural components, adjustment boltmay be used to adjust the position of the bone segment B-(e.g., severed distal metatarsal head) along the longitudinal axis defined by body. For example, the adjustment boltmay be rotated in a first direction (e.g., clockwise) to cause the second componentto move along first componentand shorten length of body, which in turn will move the bone segment B-coupled to the second componentproximally towards the rest of the bone B-(e.g., a metatarsal). Rotation of the adjustment boltin a second direction (e.g., counterclockwise) may cause the second componentto move along first componentin the opposite direction to increasing a length of bodyand move the bone segment B-distally.

The basemay be used with a targeting device, such as targeting deviceshow in. Note that while targeting device (or guide)is shown as being removably coupled to base, the targeting guideand basemay be permanently coupled to one another such that they form a unitary construct. Targeting deviceincludes a first end, which may also be referred to as a coupling end, and a second end, which may also be referred to a targeting end. Coupling enddefines a holeextending from an upper surfaceto a lower surface. Holeis sized and configured to receive a fixation device, such the same k-wire or pin P-that is received within holedefined by the second componentof body.

Targeting endincludes an extensionthat extends in a direction away from the axis of targeting guidethat extends from coupling endto the targeting end. For example, extensionmay extend in a direction that is parallel to an axis defined by holeas shown in. The lower portionof extensiondefines a pair of parallel guide holes or slots-,-(collectively, “guide holes” or “guide slots”). The guide holesmay be positioned parallel to one another and sized and configured to receive a fixation element, such as a k-wire or pin, or an insert or sleeve(shown in). If an insert or sleeveis used, then the insert or sleevemay itself define a holesized and configured to receive a fixation element.

In some embodiments, extensiondefines another holethat extends laterally through extensionas best seen in. Put another way, holeextends at an obliquely or perpendicularly with respect to the guide holes. Holeis sized and configured to receive a k-wire or pin therein for securing the targeting guideto a bone as described in greater detail below.

As noted above, the baseand targeting guidemay be used as a system for performing a MIS osteotomy for bunion correction or other surgical procedure.is a flow diagram of one example of a method that may be performed using a baseand targeting guidein accordance with some embodiments.

At block, the base may be placed. For example, the basemay be positioned over a foot such that the holeis located over the distal metatarsal head and holes,,are positioned over another (e.g., proximal) portion of the same metatarsal. In some embodiments, the baseis coupled to the metatarsal by inserting fixation elements (e.g., k-wires or pins) through hole, holeand one or more holes. The basemay be coupled to the metatarsal prior to making a cut through the metatarsal to sever the distal metatarsal head from the rest of the metatarsal. However, one of ordinary skill in the art will appreciate that basemay be coupled to the metatarsal and metatarsal head after the metatarsal head is severed.

At block, the bone may be adjusted using the base. For example, assuming the bone to which the baseis coupled has been severed or segmented, the thumbscrewmay be used to adjust the relative location of one bone segment B-relative to another bone segment B-. As described above, the rotation of thumbscrewcauses the thumb screwto advance into hole, which in turn results in the leading end of thumbscrewto press against arm(and, in some embodiments, componentof arm) thereby pivoting armabout the pivot axisshown in(and fixation element P-shown in).

In embodiments in which bodyincludes multiple components, e.g., components,, adjustment screwmay also be used to adjust the relative location of one bone segment B-relative to another bone segment B-. For example, the adjustment boltmay be rotated in a first direction (e.g., clockwise) to cause the second componentto move along first componentand shorten length of body, which in turn will move the bone segment B-coupled to the second componentproximally towards the rest of the bone B-(e.g., a metatarsal). Rotation of the adjustment boltin a second direction (e.g., counterclockwise) may cause the second componentto move along first componentin the opposite direction to increasing a length of bodyand move the bone segment B-distally.

Further, as discussed above, componentsandmay be configured to rotate relative to one another. For example, componentmay be configured to rotate about the longitudinal axis of componentor provide for relative positioning of componentsandthat may enable a bone (or bone segment), such as a first metatarsal, coupled to one of the components (e.g., component) to be rotated about a longitudinal axis of the bone.

Referring again to, the targeting guideis placed into position at block. In some embodiments, the targeting guideis placed into position by aligning holedefined by the coupling endof targeting guidewith the fixation element P-(e.g., pin or k-wire) and then sliding the targeting guideonto the fixation element P-. With the coupling endof the targeting guidecoupled to the fixation element, the targeting endmay be moved into its desired position by rotating the targeting guideabout the fixation element. Once the desired position of targeting endhas been achieved, another fixation element P-(e.g., a k-wire or pin) may be inserted through lateral holeand into bone (e.g., the proximal metatarsal portion or another bone) to fix the position of the targeting guide.

At, the bone segments may be fixed. In some embodiments, k-wires may be inserted through the guide holes or slots(or holesthrough sleeves or inserts) and into the metatarsal segments (i.e., the severed metatarsal head and remaining portion of metatarsal) to fix them relative to one another. Fasteners, such as fastenersas described in commonly assigned U.S. patent application Ser. No. 15/756,446, which is incorporated by reference herein in its entirety, may then be inserted over the k-wires to fix the position of the severed metatarsal head relative to the rest of the metatarsal.

The method illustrated inmay be used in connection with other systems and devices. For example,illustrate another example of a system in accordance with some embodiments. Referring first to, a basemay include an anchor memberthat is coupled to an angled bodyvia a pivoting arrangement. In some embodiments, the pivot point about which anchor memberand bodymay pivot is located along an axis defined by holeformed in anchor memberand a holeformed through a first componentof bodyas described in greater detail below.

provide various view of an anchor memberin accordance with some embodiments. Referring first to, the holedefined by anchor memberextends through first and second hinge components-,-(collectively, “hinge components”) that are separated from one another by a gap.

Anchor membermay define a threaded holeextending from a first sideto a second side. Threaded holemay be sized and configured to engage thumb screwas shown in, which is similar to thumb screwdescribed above and is described in greater detail below. Another holemay extend from sidethrough anchor memberto side. In some embodiments, holeis disposed parallel to holeand perpendicular to hole. Holesandmay be sized and configured to receive fixation elements, such as a pins or k-wires, for coupling anchor memberto a bone or bone segment as described herein.

In some embodiments, bodyincludes a first componentand a second componentthat are coupled together such that componentmay move relative to first component. A person of ordinary skill in the art will further understand that, although bodyis described as including multiple components, bodymay be provided as a unitary member. As shown in, which is an isometric view of componentof body, one endof componentincludes one or more hinge components-,-,-(collectively, “hinge components”) that are configured to engage hinge componentsof anchor member. For example, hinge componentsare spaced apart from one another by gaps-,-(collectively, “gaps”). Note that, while three hinge componentsand two gapsare shown in, fewer or more hinge componentsand gapsmay be provided without departing from the scope and spirit of the disclosure. Each of the hinge componentsdefines a holethat is sized and configured to receive a fixation element, such as a k-wire or pin, for coupling the bodyto a bone or bone segment. In some embodiments, hinge componentsextend at an angle away from a longitudinal axis defined by componentbetween endand end.

Componentmay include a portionhaving a reduced size (e.g., width) such that one or more shoulders-,-(collectively, “shoulders”) are provided adjacent to end. One or more channels-,-(collectively, “channels”) extend from endtowards endalong the portion. Componentmay also define a hole, which may be at least partially threaded, that extends through componentfrom endto end.

One example of the second componentis illustrated in. Componentextends from a first sideto a second sideand is substantially hollow. For example, sidedefines an openingthat extends inwardly into component(), and sidedefines a hole() that is in communication with opening. Openingmay extend to a depth such that a majority of the length of the first component, or at least a substantial portion of the reduced size portionof component, may be received within opening. Holeis sized and configured to receive an adjustment bolttherein. Adjustment boltmay be the same or similar as adjustment boltdescribed above.

One or more protrusions-,-(collectively, “protrusions”) may extend inwardly into opening. Protrusionsare sized and configured to align with and be received within channelsthat extend along component. Although protrusionsare shown as being part of componentand channels are shown as being defined by component, one of ordinary skill in the art will understand that the configuration could be reversed and/or each component,could include a combination of a protrusion and a channel.

One or more holes-,-(collectively, “holes”) may extend from sideto sidethrough componentas best seen in. Holes may be sized and configured to receive a pin or other coupling device for securing an adjustment boltto component.

In some embodiments, componentincludes a curved extensionextending from side. Extensionmay include a pair of spaced apart arms-,-(collectively, “arms”) that are separated from each other by slot or gapbest seen in. Each arm-,-may define a respective slot-,-(collectively, “slots”) that extends through the arm. In some embodiments, the slotshave the same curvature as the curvature of the extension. However, one of ordinary skill in the art will understand that slotsmay have other shapes. Slotsare sized and configured to receive a dowel, cross-pin or other securement device as described below. Each armmay also include a shelfextending inwardly from the arm (i.e., towards gap) as shown in.

illustrate one example of a mounting componentthat may be coupled to and supported by the extension. Mounting componentincludes a bodythat may have a curved shaped similar to the shape of extension. One sideof componentdefines one or more holes-,-(collectively, “holes”) that extend through bodyto side. Holesmay be sized and configured to receive fixation elements (e.g., k-wire or pin) therethrough.

Side, which may be positioned between sidesand, may include an outwardly extending protrusion, which defines a holethat extends through body. In some embodiments, holeis threaded. Sidemay also define one or more holes-,-(collectively, “holes”) that extend through body. Holesmay be sized and configured to receive dowel, cross-pins, or other securement for coupling mounting componentto armsof extensionvia slots.

As best seen in, sidedefines a pair of slots-,-(collectively, “slots”) that are formed on either side of a guide. Slotsare positioned and dimensioned to correspond to receive the upper portions of armstherein when guideis received within the gap. In some embodiments, guidemay contact or abut shelf; however, one of ordinary skill in the art will understand that the shelfmay provide clearance for guide.

Threaded holeis sized and configured to receive a thumbscrewtherein as best seen in. Thumbscrewmay be rotated relative to mounting component, which results in thumb screwbeing advanced into or out of hole. Advancement of the thumb screwinto holewill result in the leading end of thumb screwcontacting the extensionto secure the location of mounting componentalong mounting component.

show the baseassembled and coupled to bone, andshow a targeting guidecoupled to the base. Various views of the targeting guideare shown in. Referring first to, targeting guideincludes a bodyhaving first and second arm portions-,-(collectively, “arms”) that diverge from one another. Arm-terminates at a coupling end, and arm-terminates at a targeting end.

Coupling enddefines one or more slots-,-(collectively, “slots”), which may have arcuate shapes, and a hole. Slotsand holeare sized and configured to receive a fixation element, such as a k-wire or pin, therein as best seen in. With a fixation element received within holeand at least one of the slots, the targeting guidemay be able to pivot within a certain pre-defined range (i.e., the range provided by the length of the slots). A person of ordinary skill in the art will understand that the targeting guidecould be provided with only a hole, which would enable the targeting guide to pivot in a complete circle. Alternatively, one could insert a fixation element only into holeto achieve the same function.

Targeting endincludes a first hole that extends through arm-in a first direction and one or more slots/holes-,-(collectively, “slots,” “holes,” or “slots/holes”) that extend in a second direction, which may be different from the first direction (e.g., oblique or perpendicular). Slots/holesare sized and configured to receive a fixation element, such as a k-wire or pin therein. In some embodiments, slots/holeis sized and configured to receive sleeve, which itself defines a holesized and configured to receive a fixation element as described above. Holeis sized and configured to receive a k-wire or pin therein for securing the targeting guideto a bone in a similar manner as holedescribed above.

The function of baseand targeting guideis similar to the function of baseand targeting guidedescribed above. One difference is due to the presence of the extension, which enables the mounting member, which supports targeting guide, to slide in an arcuate manner. In some embodiments, the arc is swept about an axis of the bone portion to which the baseis coupled.

illustrate another example of a system in accordance with some embodiments. The system shown inalso may include a baseand a targeting guide. Referring first to, baseincludes a first body component, which includes a pair of divergent legs-,-(collectively, “legs”). Leg-extends from a from second leg-and terminates at end. One or more slots-,-(collectively, “slots”) extend lengthwise along leg-. The enddefines a hole, which may be threaded along at least a part of its length. Holeextends lengthwise through leg-. The opposite end of the hole(shown inmay have an enlarged diameter to form a clearance areaas best seen in.